The following data is part of a premarket notification filed by University Of Utah/school Of Medicine with the FDA for Growth Guidance Plate.
| Device ID | K031493 |
| 510k Number | K031493 |
| Device Name: | GROWTH GUIDANCE PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | UNIVERSITY OF UTAH/SCHOOL OF MEDICINE P.O. BOX #58246 Salt Lake City, UT 84158 |
| Contact | Peter M Stevens |
| Correspondent | Peter M Stevens UNIVERSITY OF UTAH/SCHOOL OF MEDICINE P.O. BOX #58246 Salt Lake City, UT 84158 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-12 |
| Decision Date | 2003-11-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242513568 | K031493 | 000 |
| 18054242513261 | K031493 | 000 |
| 18054242513247 | K031493 | 000 |
| 18054242513230 | K031493 | 000 |
| 18054242513223 | K031493 | 000 |
| 18054242513216 | K031493 | 000 |
| 18054242513209 | K031493 | 000 |
| 18054242513193 | K031493 | 000 |
| 18054242513131 | K031493 | 000 |
| 18054242513124 | K031493 | 000 |
| 18033509852664 | K031493 | 000 |
| 18033509852657 | K031493 | 000 |
| 18033509852640 | K031493 | 000 |
| 18033509852633 | K031493 | 000 |
| 18054242513278 | K031493 | 000 |
| 18054242513285 | K031493 | 000 |
| 18054242513537 | K031493 | 000 |
| 18054242513520 | K031493 | 000 |
| 18054242513469 | K031493 | 000 |
| 18054242513452 | K031493 | 000 |
| 18054242513445 | K031493 | 000 |
| 18054242513438 | K031493 | 000 |
| 18054242513421 | K031493 | 000 |
| 18054242513353 | K031493 | 000 |
| 18054242513346 | K031493 | 000 |
| 18054242513322 | K031493 | 000 |
| 18054242513315 | K031493 | 000 |
| 18054242513308 | K031493 | 000 |
| 18054242513292 | K031493 | 000 |
| 18033509852626 | K031493 | 000 |